(b)(4).Medical products: unk m2a magnum head, catalog#: ni, lot# ni; unk m2a magnum taper, catalog#: ni, lot# ni; unk stem, catalog#: ni, lot# ni; therapy date: ni.Mantymaki, h., junnila, m., lankinen, p., seppanen, m., vahlberg, t., & makela, k.(2017).Systematic screening of adverse reactions to metal debris after recap-m2a-magnum metal-on-metal total hip arthroplasty.Systematic screening of adverse reactions to metal debris after recap-m2a-magnum metal-on-metal total hip arthroplasty.Doi:https://doi.Org/10.1177/1457496916683093.Reported event was unable to be confirmed.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-06033, 0001825034-2017-06034 and 0001825034-2017-06035.
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